![]() ![]() Finch therapeutics trial#Reported Positive Topline Results from PRISM-EXT Phase 2 Open-Label Trial of CP101 in Recurrent CDI: In November 2021, Finch reported topline data from PRISM-EXT in which 80.3% and 78.8% of participants who received CP101 following standard-of-care (SOC) antibiotics were without CDI recurrence through 8 weeks and 24 weeks post-treatment, respectively (n=132).Clinical Data from PRISM-EXT and PRISM3 Phase 2 Trials Accepted for Presentation at Digestive Disease Week (DDW) 2022: Today, Finch announced that data from its PRISM-EXT Phase 2 open-label trial and its PRISM3 Phase 2 placebo-controlled trial will be presented in May at DDW 2022. ![]() Finch is evaluating the extent of the expected delay to the timing for resuming enrollment in PRISM4 and, based on manufacturing timelines, expects at least a one quarter delay. ![]() Enrollment in PRISM4 will remain paused until Finch is able to resolve the clinical hold, address the most recent FDA feedback and conduct additional manufacturing activities to satisfy requests related to SARS-CoV-2 donor screening. Subsequent to the recent clinical hold letter, Finch has received additional correspondence from the FDA requesting changes to the testing algorithm used to diagnose suspected CDI recurrences in PRISM4, as well as additional information about the proposed statistical analysis plan for PRISM4 and the validation package for one of Finch’s release tests. Finch therapeutics update#
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